NCT06952998

Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease

Randomized Clinical Trial, Controlled With Conventional Treatment to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Biotechnology Institute IMASD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized clinical trial that compares the effectiveness of Plasma Rich in Growth Factors (PRGF) with conventional treatment for healing foot ulcers in diabetic patients who also have peripheral arterial disease. The goal is to assess how well PRGF promotes healing over a six-month period.

Conditions

• Foot Ulcers, Diabetic

Interventions

Type	Name	Description
DRUG	Topical application of Plasma Rich in Growth Factors (PRGF)	Topical application of PRGF will be maintained each time the patient undergoes the conventional treatment. The frequency of conventional treatment will be determined by the health specialist according to the evolution of the ulcer. The treatment will be maintained until complete wound closure or until the end of the follow-up period (6 months).
PROCEDURE	Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).	Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic). The "TIME" dynamic wound closure strategy will be followed, which summarizes the four key points to stimulate the natural healing process: control of non-viable tissue, control of inflammation and infection, control of exudate and stimulation of the edges. After healing, chlorhexidine spray will be applied topically to these patients. The frequency of conventional treatment will be determined by the health specialist according to the evolution of the ulcer. Treatment will be maintained until complete wound closure or until the end of the follow-up period (6 months).

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-05-30
• Completion: 2027-05-30
• First posted: 2025-05-01
• Last updated: 2025-09-11

Locations

1 site across 1 country: Spain